MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-29 for SCISSORS CP616-13 130MM CVD RAGNELL manufactured by Medtronic Xomed Instrumentation S.a.s. Le Pavillon.
[3810595]
The device (part number cp616-13) was returned to mxi service and repair. During a minor surgical procedure, the ragnell scissors cut the skin of a patient. In the same case, a second set did the same. The second set was disposed of. The site reported that there was no impact to the patient. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[11094065]
The device (part number cp616-13) was evaluated and indicated that one of the scissors' blades was broken at the center screw. Observation of the rupture area indicates a corroded area around the center screw. No material defect was observable in the rest of the fracture area. Observation of a corroded area at the area of the fracture indicates a pre-existing crack present before the break. Considering the absence of material defects in the rest of the fracture area, the age of the instrument and the absence of similar cases after analysis of our post-market data, mxi can reasonably conclude that the instrument was likely subjected to shocks during use or reprocessing that caused a crack to form. This crack weakened the instrument and led to the observed breakage. (b)(6). Note: this mdr is being filed as a result of an internal review of complaints from medtronic's facility in (b)(6). This review was conducted to resolve several issues discovered in the mxi complaint handling process. Issues resolved include the misclassification of devices returned for repair, as well as gaps in reporting. Mxi capa (b)(4) was opened to address these issues. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00397 |
| MDR Report Key | 3339026 |
| Report Source | 01,07 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-03-11 |
| Date of Event | 2013-03-06 |
| Date Mfgr Received | 2013-03-11 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2013-09-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JONATHAN SCHLECH |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| Manufacturer G1 | MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON |
| Manufacturer City | SAINT-AUBIN-LE-MONIAL 03160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 03160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCISSORS CP616-13 130MM CVD RAGNELL |
| Product Code | HRR |
| Date Received | 2013-08-29 |
| Returned To Mfg | 2013-03-11 |
| Model Number | CP616-13 |
| Lot Number | 04/11 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON |
| Manufacturer Address | SAINT-AUBIN-LE-MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-29 |